FDA 510(k) Application Details - K984161

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K984161
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS 1106 CHILTERN DR. WALNUT CREEK, CA 94596 US Other 510(k) Applications for this Company
Contact	ROBERT MORTON Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	IYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/1998
Decision Date	05/05/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review